Senior Process Engineer

Senior Process Engineer

Location:

Noblesville, IN, United States, 46060

Date:
Jul 13, 2026

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world‑class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life‑threatening diseases to over 14 million patients annually.

The name “Curium” honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline “Life Forward” represents our commitment to securing a brighter future for all those we serve:
An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

The Senior Process Engineer – Strontium provides technical discipline and leadership required to maintain, plan and implement robust and capable cyclotron and cyclotron‑derived API manufacturing processes, as well as upstream process activities at the Noblesville, IN facility.

This role will be responsible for performing the following: identifying and implementing improvements and new technologies to processes to increase productivity, improve quality and reduce costs; leading API process equipment troubleshooting efforts along with coordinating other support groups to return equipment to service; serving as a Subject Matter Expert (SME) and leading API product/process failure investigations, implementing corrective actions, and preparing sound scientific reports;

authoring and providing technical support for developing new processes and equipment documents including URS (user requirements specifications), DOE's (design of experiments), and validation documents; authors and/or reviews change control submissions to ensure the validated status of equipment is maintained; reviewing, monitoring and trending operating data, consistently applying operational excellence and continuous improvement skills/tools in evaluating the data, and issuing related reports and recommendations for maintaining and improving process reliability;

and providing operations support to both the Cyclotron and Strontium Chemistry departments as needed.

Work Schedule:

Monday – Friday 8 am – 5 pm, unless business needs dictate otherwise. This position supports production in a 24‑hour manufacturing facility and may require evenings, nights, weekends, and some holidays with occasional overtime.

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Leading process troubleshooting and remediation efforts for both the cyclotron and strontium chemistry departments.
• Maintain control of API process changes including change control management and documentation.
• Providing adequate and documented monitoring of the department API processes through trending, running reports, and tracking through SPC (Statistical Process Control) or other tools.
• Identify and support departmental change initiatives for continual process improvement, specifically around Operational Excellence, 6‑Sigma and Lean Manufacturing applications. Will serve as a departmental driver for cost reduction initiatives.
• Assist in the development and maintenance of process equipment, procedures, batch records, and training materials.
• Ability to influence proper operating procedures during the manufacture of API pharmaceuticals (Compliance with regulations, GMP behaviors/techniques, etc.).
• Leads and plans strontium chemistry operations as needed.
• Executes and improves IQOQs, calibration procedures, and protocols for cyclotron and chemistry equipment.
• Conducts troubleshooting, maintenance, and improvement initiatives for hot cells, tele‑manipulators, and production equipment.
• L…